MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO; CATHETER, CONTINUOUS FLUSH

Model Number	80619
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 07mar2022.It was reported that resistance was felt upon delivery of device.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified internal iliac artery.A direxion catheter - infusion was selected for use.During the procedure, resistance was felt upon advancing into the chronic lesion.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the device was fracture 43.2cm from the hub.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed damage in the form of a fracture located 43.2cm from the hub.The fracture looked to be consistent with a tensile force breaking as the device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: DIREXION HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13934460
• Report Number: 2134265-2022-03198
• Device Sequence Number: 4590457
• Product Code: KRA
• UDI-Device Identifier: 08714729839507
• UDI-Public: 08714729839507
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0024576814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male